PROTOCOL THS 94-002 
REVISED 05/24/94 
PAGE 1 of 6 
THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
Protocol Title: Clinical Protocol for Modification of Tumor Suppressor Gene 
Expression and Induction of Apoptosis (cancer cell death) in 
Non-Small Cell Lung Cancer (NSCLC) with an Adenovirus 
Vector Expressing Wlldtype (normal) p53 and Cisplatin 
1 . 
Participant's Name I.D. Number 
You have the right to know about the procedures that are to be used in your 
participation in clinical research so as to afford you an opportunity to make the 
decision whether or not to undergo the procedure after knowing the risks and 
hazards involved. This disclosure is not meant to frighten or alarm you; it is simply 
an effort to make you better informed so that you may give or withhold your 
consent to participate in clinical research. This informed consent does not 
supersede other consents you may have signed. 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF THE STUDY: Some lung cancers seem to arise because 
problems occur in a part of the cells (a particular gene called "p53") that 
usually stops cancer. In this clinical research study the investigators are 
trying to insert a normal copy of the p53 gene into the lung cancer cells to 
see if this will cause the cancer cells to stop growing. As a "vector" that 
is, as a vehicle to get the p53 gene into the cells, the investigators will use 
an adenovirus (related to cold viruses) that has been altered so it cannot 
reproduce itself. Because the investigators are at an early stage in the 
research, the investigators do not expect to cure the patients who 
participate; instead, the immediate purpose of the study is to find out what 
dose of vector can be used without harming patients and whether the new 
p53 genes will cause cancer cells to stop growing. 
3. DESCRIPTION OF RESEARCH: The experimental protocol is as follows: 
Patients for this study will be selected from among patients with non-small 
cell lung cancer who are not now candidates for radiation therapy or 
surgery. Patients with local tumors that cannot be removed with surgery or 
have recurred after radiation can participate. It is not necessary that the 
patient received chemotherapy (drugs) alone but chemotherapy may be an 
alternative treatment. These tumors will be directly injected with the 
adenovirus. Patients with fluid in the chest caused by tumor cells will also 
participate and will have the adenovirus directly injected in the fluid. 
Patients who have known tumors within their airway can also participate. 
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